Data further support choice of patient population and dosing regimen in CervoMed's planned Phase 3 trial in dementia with Lewy bodies (DLB)
DLB is the second most common progressive dementia, affecting millions worldwide, and has no approved treatments in the United States or European Union
BOSTON, March 12, 2026 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO) (CervoMed or the Company), a clinical-stage biotechnology company developing treatments for age-related brain disorders, today announced that neflamapimod, an oral, small molecule, drug candidate targeting critical disease processes underlying degenerative disorders of the brain, will be featured in an oral presentation and a scientific symposium at AD/PD 2026 in Copenhagen, Denmark, taking place March 17-21, 2026.
In the Phase 2b RewinD-LB trial, neflamapimod demonstrated a statistically significant and clinically meaningful slowing of clinical progression in patients with dementia with Lewy bodies (DLB) who did not have Alzheimer’s disease (AD) co-pathology during the trial’s extension phase. The secondary analyses of data from the trial to be presented at AD/PD 2026 will include new outcomes by pre-specified plasma pTau181 levels that further support the cutoff to be utilized in the Company’s planned Phase 3 trial in DLB patients to enrich for those without AD co-pathology.
The primary and secondary analyses of the study will be presented by Dr. John-Paul Taylor, MBBS(hons) MRCPsych PhD, Professor of Translational Dementia Research at Newcastle University, United Kingdom (UK) and Chief Investigator of the RewinD-LB trial for the UK.
In addition, CervoMed will be sponsoring a scientific symposium that focuses on how advances in DLB research are leading to new, mechanism-based drug development strategies. The symposium will include presentations from Dr. Niels Prins, MD, PhD, Brain Research Center, Amsterdam, and Dr. John Alam, CEO, CervoMed, and will highlight scientific, mechanistic, pharmacologic, and clinical data supporting the inhibition of p38 map kinase as a potential promising treatment for DLB. This will include results of new PK/PD analyses (i.e., blood drug concentration relationships) from the RewinD-LB trial that increase the understanding of neflamapimod dose-response in DLB and support the Company’s proposed dosing regimen for its planned Phase 3 trial.
Oral Presentation
Title: Neflamapimod Treatment Effects In Patients With Dementia With Lewy Bodies Without Concomitant Ad Pathology In The Rewind-LB Clinical Study (NCT05869669)
Session: ID 2617
Location: Auditorium 10
Authors: John-Paul Taylor, Stephen Gomperts, Lawrence Honig, Niels Prins, Amanda Gardner, Kelly Blackburn, John Alam, James Galvin
Date/Time: Saturday, March 21 at 14:25-14:40 CET
Scientific Symposium
Title: From Mechanisms to Medicines: Advancing Drug Development in Dementia With
Lewy Bodies
Location: Hall A1
Presenters: Niels Prins, MD, PhD, Brain Research Center, Amsterdam and John Alam, MD, CEO CervoMed
Date/Time: Friday, March 20, 2026 at 16:20 CET
About CervoMed
CervoMed is a clinical-stage company developing treatments for age-related brain disorders. Its lead drug candidate, neflamapimod, is an oral small molecule targeting critical disease processes underlying degenerative disorders of the brain by inhibiting a key enzyme involved in neuroinflammation and neurodegeneration. CervoMed’s recently completed Phase 2b RewinD-LB trial evaluated neflamapimod in patients with DLB, enriched for those without AD co-pathology. The Company plans to initiate a global, pivotal Phase 3 trial in patients with DLB, enriched for those without AD co-pathology, in the second half of 2026, subject to available funding.
Forward-Looking Statements
This press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, regarding the intentions, plans, beliefs, expectations or forecasts for the future of the Company, including, but not limited to: that neflamapimod will have any particular pharmacokinetic profile or achieve any specific plasma drug concentrations, including whether such profile or concentrations will replicate those observed in any prior clinical trial or nonclinical study; the therapeutic potential of neflamapimod in DLB or any other indication, including the degree of sustainability of any therapeutic effects; the anticipated timing and achievement of clinical and development milestones, including the Company’s initiation of the Company’s planned Phase 3 trial in DLB patients without AD co-pathology and the announcement of any data therefrom; any other expected or implied benefits or results, including the extent (if any) to which neflamapimod may demonstrate efficacy or other clinical or biomarker improvements in patients; and the Company’s need to acquire sufficient funding, including funding for its planned Phase 3 trial. Terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “aims,” “seeks,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately,” “potential,” “target,” “project,” “contemplate,” “predict,” “forecast,” “continue,” or other words that convey uncertainty of future events or outcomes (including the negative of these terms) may identify these forward-looking statements. Although there is believed to be reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company’s control and, as a result, actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risks and uncertainties include, among other things, those related to: the Company’s available cash resources, the availability of additional funds on acceptable terms, and the Company’s ability to continue as a going concern; the results of the Company’s clinical trials, including RewinD-LB; the likelihood and timing of any regulatory approval of neflamapimod or the nature of any feedback the Company may receive from the FDA; the ability to implement business plans, forecasts, and other expectations in the future; general economic, political, business, industry, and market conditions, inflationary pressures, and geopolitical conflicts; and the other factors discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission (SEC) on March 17, 2025, and other filings that the Company may file from time to time with the SEC. Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified). The Company does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except to the extent required by law.
Contacts
Media:
Biongage Communications
lisa.guiterman@gmail.com
202-330-3431
Investor Relations:
Argot Partners
cervomed@argotpartners.com
212-600-1902
